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Developing a Mobile Method to Measure THC-induced Impairment (AIS)

Primary Purpose

Measuring THC-induced Cognitive Impairment Using a Mobile Application

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dronabinol
Placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Measuring THC-induced Cognitive Impairment Using a Mobile Application

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18-35 years old, males and females (N=44; 36 completers; 18 men, 18 women)
  2. BMI 19-26
  3. High school education, fluent in English
  4. Experienced non-daily marijuana users

    Exclusion Criteria:

  5. Current drug/alcohol abuse or dependence
  6. Past year drug/alcohol dependence
  7. Diagnosis with drug treatment for psychosis/bipolar/schizophrenia
  8. Past year major depression
  9. Panic/anxiety attacks in past 2 months
  10. PTSD
  11. ADHD
  12. Cardiovascular illness, high blood pressure, abnormal EKG
  13. Current medications
  14. Pregnant or planning to become pregnant

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

7.5 mg THC

15 mg THC

Arm Description

Outcomes

Primary Outcome Measures

Simple Reaction Time
In this reaction time task, the user is asked to shake the device in response to a visual clue on the device's screen. The user makes three attempts, in which he or she must shake or move the device with an acceleration that is greater than the value of the thresholdAcceleration property within the given time. The task finishes when the user successfully completes the attempts as instructed in the task. Data collected by this task is in the form of ORKReactionTimeResult objects. Each of these objects contain a timestamp representing the delivery of the stimulus and an ORKFileResult object that references the motion data collected during an attempt.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2019
Last Updated
January 14, 2019
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03804840
Brief Title
Developing a Mobile Method to Measure THC-induced Impairment
Acronym
AIS
Official Title
A Mobile Prototype for a Field Sobriety Test for Cannabis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Marijuana use, for both recreational and therapeutic purposes, is becoming increasingly common as states remove restrictions on use. The increased use raises new concern about the safety of this drug, including its ability to impair basic cognitive and psychomotor tasks, and whether the users are aware of their impairment. We propose to design a simple performance test that users can use in the field, using a cell phone, to assess their level of impairment relative to their own drug-free state. In this preliminary study, we will compare participants' simple task performance after a known dose of delta-9-tetrahydrocannabinol (THC), or placebo, administered under double-blind conditions. In our app the participants will be asked to gauge their own perceived level of impairment (as determined by self-ratings and judgments of impairment) as well as their actual impairment (as gauged by the app), providing important feedback and training about their ability to detect impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measuring THC-induced Cognitive Impairment Using a Mobile Application

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
7.5 mg THC
Arm Type
Active Comparator
Arm Title
15 mg THC
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dronabinol
Intervention Description
THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication (Broyd et al, 2016; Hartman and Huestis, 2013).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Simple Reaction Time
Description
In this reaction time task, the user is asked to shake the device in response to a visual clue on the device's screen. The user makes three attempts, in which he or she must shake or move the device with an acceleration that is greater than the value of the thresholdAcceleration property within the given time. The task finishes when the user successfully completes the attempts as instructed in the task. Data collected by this task is in the form of ORKReactionTimeResult objects. Each of these objects contain a timestamp representing the delivery of the stimulus and an ORKFileResult object that references the motion data collected during an attempt.
Time Frame
Assessed two hour post intervention at peak effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-35 years old, males and females (N=44; 36 completers; 18 men, 18 women) BMI 19-26 High school education, fluent in English Experienced non-daily marijuana users Exclusion Criteria: Current drug/alcohol abuse or dependence Past year drug/alcohol dependence Diagnosis with drug treatment for psychosis/bipolar/schizophrenia Past year major depression Panic/anxiety attacks in past 2 months PTSD ADHD Cardiovascular illness, high blood pressure, abnormal EKG Current medications Pregnant or planning to become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Pabon
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60615
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Developing a Mobile Method to Measure THC-induced Impairment

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